不符合质量规格的原料以一种适当的文件(如检验报告)进行存档。这份文件附在最终产品的批生产记录中。

Materials, which fail to meet the specification, are documented in an appropriate document (i. e. analytical report). The document is attached for the finished material to the batch production record.

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组织编写生产管理文件，批生产记录，修订工艺规程，及GMP相关记录，确保生产工作有法可依。

Draft out production management document batch production record, modify process procedure GMP relative record, assure production work has regulation to follow.

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